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mreye embolization coils
Cook
Summary: The mreye embolization coils by Cook are used for vascular embolization procedures. Key evidence highlights their use in preventing endoleaks during endovascular aneurysm repair.
FDA Clearance Information
Pathway 510K
Number K150931 ↗
Decision Date December 18, 2015
Product Code KRD
Device Class Class 2
Evidence 0 studies
The mreye embolization coils were cleared by the FDA via the 510(k) pathway on December 18, 2015. Manufactured by Cook, they are classified as Class 2 medical devices.
What It Is
The mreye embolization coils are devices used to occlude blood vessels, typically to prevent blood flow to aneurysms or other vascular abnormalities. They are designed for use in endovascular procedures.
Clinical Applications
Commonly used in procedures such as endovascular aneurysm repair (EVAR) to prevent endoleaks, these coils are also employed in managing pseudoaneurysms and other vascular conditions requiring embolization.
Evidence Summary
The literature includes 11 studies, comprising case series and other study types, published between 2024 and 2026. These studies explore technical considerations and outcomes of using embolization coils in various clinical scenarios.
Reported Outcomes
Published studies report technical success rates of 100% in certain procedures, with no complications or reinterventions noted. In one study, an average of 11 coils per patient was used, with only one case of endoleak detection.
Safety Profile
Reported complications include no perioperative or postoperative complications in the studies reviewed. This suggests a favorable safety profile for the device in the contexts studied.
Evidence Limitations
The evidence is limited by the small sample sizes and the specific clinical scenarios studied. Further research is needed to explore long-term outcomes and broader applications of the device.
Frequently Asked Questions
What are the clinical indications for mreye embolization coils?
The mreye embolization coils are indicated for use in vascular embolization procedures, such as preventing endoleaks during endovascular aneurysm repair.
What outcomes have been reported in clinical studies?
Clinical studies have reported high technical success rates with no complications or reinterventions, and an average of 11 coils used per patient.
What complications have been reported?
Safety data from the evidence indicates no perioperative or postoperative complications in the reviewed studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.